FDA Adverse Event
Injury
Summary report: N
PROTECTA CRT-D
MDR report key: 4162449
·
Received October 10, 2014
Report
- Report Number
- 9614453-2014-02520
- Event Type
- Injury
- Date Received
- October 10, 2014
- Date of Event
- June 18, 2014
- Report Date
- August 14, 2014
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- NIK
- PMA / PMN Number
- P010031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE RETURNED DEVICE INDICATED NORMAL BATTERY DEPLETION.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE INDICATED RECOMMENDED REPLACEMENT TIME (RRT) EARLIER THAN EXPECTED. THE DEVICE WAS EXPLANTED AND REPLACED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 639796 | PROTECTA CRT-D | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO | NIK | IPG MFG SWITZERLAND | D364TRG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00083 YR | Hospitalization| R |